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    INSULIN FORMULATIONS FOR RAPID UPTAKE
    4.
    发明申请
    INSULIN FORMULATIONS FOR RAPID UPTAKE 有权
    胰岛素制剂用于快速摄取

    公开(公告)号：US20100227795A1

    公开(公告)日：2010-09-09

    申请号：US12397219

    申请日：2009-03-03

    申请人： Solomon S. Steiner ,  Roderike Pohl ,  Ming Li ,  Robert Hauser

    发明人： Solomon S. Steiner ,  Roderike Pohl ,  Ming Li ,  Robert Hauser

    IPC分类号： A61K38/28 ,  A61P3/10

    CPC分类号： A61K9/0019 ,  A61K38/00 ,  A61K38/28 ,  A61K47/12 ,  A61K47/183 ,  C07K14/62

    摘要： Injectable insulin formulations with improved stability and rapid onset of action are described herein. The formulations may be for subcutaneous, intradermal or intramuscular administration. In the preferred embodiment, the formulations are administered via subcutaneous injection. The formulations contain insulin in combination with a chelator and dissolution agent, and optionally additional excipients. In the preferred embodiment, the formulation contains human insulin, a zinc chelator such as EDTA and a dissolution agent such as citric acid or sodium citrate. These formulations are rapidly absorbed into the blood stream when administered by subcutaneous injection. In the preferred embodiment, the insulin is provided as a clear liquid, neutral pH, in a multi-use sterile vial. In an alternative embodiment, the insulin is provided as a powder in a sterile vial. This is mixed with a diluent containing a pharmaceutically acceptable carrier, such as water, a zinc chelator such as EDTA and a dissolution agent such as citric acid shortly before or at the time of administration. In another embodiment, the insulin is stored as a frozen mixture, ready for use upon thawing.

    摘要翻译： 本文描述了具有改善的稳定性和快速起效的可注射的胰岛素制剂。 制剂可用于皮下，皮内或肌内给药。 在优选的实施方案中，通过皮下注射施用制剂。 制剂含有与螯合剂和溶解剂以及任选的其它赋形剂组合的胰岛素。 在优选的实施方案中，制剂含有人胰岛素，锌螯合剂如EDTA和溶解剂如柠檬酸或柠檬酸钠。 当通过皮下注射给药时，这些制剂被快速地吸收到血流中。 在优选的实施方案中，胰岛素以多用途无菌小瓶中的透明液体中性pH提供。 在替代实施方案中，胰岛素以无菌小瓶中的粉末形式提供。 将其与包含药学上可接受的载体如水，锌螯合剂如EDTA的稀释剂和不久之前或给药时的溶解剂如柠檬酸混合。 在另一个实施方案中，将胰岛素作为冷冻混合物储存，准备在解冻时使用。

    RAPID ACTING AND LONG ACTING INSULIN COMBINATION FORMULATIONS
    5.
    发明申请
    RAPID ACTING AND LONG ACTING INSULIN COMBINATION FORMULATIONS 有权
    快速行动和长期行动胰岛素组合制剂

    公开(公告)号：US20090137455A1

    公开(公告)日：2009-05-28

    申请号：US12324717

    申请日：2008-11-26

    申请人： Solomon S. Steiner ,  Roderike Pohl

    发明人： Solomon S. Steiner ,  Roderike Pohl

    IPC分类号： A61K38/28 ,  A61P3/00

    CPC分类号： A61K31/185 ,  A61K9/0014 ,  A61K31/19 ,  A61K31/385 ,  A61K38/28 ,  A61K47/02 ,  A61K47/10 ,  A61K47/12 ,  A61K47/18 ,  A61K47/183 ,  A61K47/26 ,  A61K2300/00

    摘要： An injectable formulation containing a combination of a rapid acting insulin and a long acting insulin has been developed wherein the pH of the rapid acting insulin is adjusted so that the long acting insulin, e.g. insulin glargine, remains soluble when they are mixed together. In the preferred embodiment, this injectable basal bolus insulin is administered before breakfast, provides adequate bolus insulin levels to cover the meal, does not produce hypoglycemia after the meal and provides adequate basal insulin for up to 24 hours. Lunch and dinner can be covered by two bolus injections of a fast acting, or a rapid acting or a very rapid acting insulin. Alternatively, through adjustment of the ratio of rapid acting insulin to long acting insulin, the long acting insulin may be shortened to a 12 hour formulation. This rapid and long acting blend is re-administered to the patient at dinner time, providing a safe and effective basal insulin level until morning. As a result, a patient using intensive insulin therapy should only inject three, rather than four, times a day.

    摘要翻译： 已经开发了含有快速作用的胰岛素和长效胰岛素的组合的可注射制剂，其中调节快速作用的胰岛素的pH，使得长效胰岛素例如。 甘精胰岛素，当它们混合在一起时，保持可溶。 在优选的实施方案中，该可注射的基础推注胰岛素在早餐之前施用，提供足够的推注胰岛素水平以覆盖膳食，在餐后不产生低血糖并提供足够的基础胰岛素达24小时。 午餐和晚餐可以通过快速作用或快速作用或非常快速作用的胰岛素的两次快速注射来覆盖。 或者，通过调整速效胰岛素与长效胰岛素的比例，长效胰岛素可缩短至12小时制剂。 这种快速和长效的混合物在晚餐时间重新施用于患者，提供安全有效的基础胰岛素水平直到早晨。 因此，使用强化胰岛素治疗的患者每天只能注射三次，而不是四次。

    Compositions for treatment or prevention of bioterrorism
    6.
    发明授权
    Compositions for treatment or prevention of bioterrorism 有权
    用于治疗或预防生物恐怖主义的组成部分

    公开(公告)号：US06991779B2

    公开(公告)日：2006-01-31

    申请号：US10347932

    申请日：2003-01-17

    申请人： Solomon S. Steiner ,  Cohava Gelber ,  Robert S. Feldstein ,  Roderike Pohl

    发明人： Solomon S. Steiner ,  Cohava Gelber ,  Robert S. Feldstein ,  Roderike Pohl

    IPC分类号： A61K9/12 ,  A61K9/72

    CPC分类号： A61K9/0075 ,  A61K9/1617 ,  A61K9/1641 ,  A61K31/46 ,  A61K31/495 ,  A61K39/00 ,  A61K39/07 ,  A61K2039/505 ,  A61K2039/55555 ,  C07K16/12

    摘要： Compositions containing biologically active molecules encapsulated in self-assembling, diketopiperazine microspheres (TECHNOSPHEREs™) and methods for making and administering such compositions are described herein. The compositions can be used to immunize individuals against agents of biological warfare. The biologically active molecules include atropine, antibodies, antigens, and antibiotics. The compositions can be placed in an inhalation device for self-administration. Pulmonary delivery of TECHNOSPHERE™ encapsulated atropine, antibodies, vaccines, and antibiotics provides an accelerated onset of immunity to the targeted disease. Furthermore, the TECHNOSPHERE™ encapsulated atropine, antibodies, vaccines, and antibiotics are stable formulations, suitable for stockpiling, rapid dissemination and mass treatment.

    摘要翻译： 包含自组装，二酮哌嗪微球体（TECHNOSPHERE TM）中的生物活性分子的组合物以及制备和施用此类组合物的方法在本文中描述。 组合物可用于免疫个体对生物战的药剂。 生物活性分子包括阿托品，抗体，抗原和抗生素。 组合物可以放置在用于自我给药的吸入装置中。 包含阿托品，抗体，疫苗和抗生素的TECHNOSPHERE TM的肺转运提供了对目标疾病免疫的加速发作。 此外，TECHNOSPHERE（TM）包裹阿托品，抗体，疫苗和抗生素是稳定的配方，适合储存，快速传播和大量治疗。

    Sublingual drug delivery device
    7.
    发明授权
    Sublingual drug delivery device 失效
    舌下给药装置

    公开(公告)号：US07658721B2

    公开(公告)日：2010-02-09

    申请号：US11037737

    申请日：2005-01-18

    申请人： Solomon S. Steiner ,  Craig Brown ,  Roderike Pohl ,  Trent Poole ,  Erik Steiner

    发明人： Solomon S. Steiner ,  Craig Brown ,  Roderike Pohl ,  Trent Poole ,  Erik Steiner

    IPC分类号： A61M37/00 ,  A61M15/00 ,  A61M16/10 ,  A61M16/00 ,  A61M11/00

    CPC分类号： A61M11/00 ,  A61M15/0028 ,  A61M15/0048 ,  A61M15/0051 ,  A61M2202/064 ,  A61M2205/073 ,  A61M2205/8225

    摘要： A drug delivery device that aerosolizes a dry powder formulation so that it forms a fine coating in the oral cavity and, more specifically in the sublingual region of the oral cavity is described herein. In the preferred embodiment, the device contains five main parts: (i) a compressed gas canister, (ii) a dispenser body (also referred to herein as the main housing ), (iii) a means for storing one or more doses of a drug formulation, (iv) a means for releasing a dose of the drug formulation such as a gas canister or spring piston and (v) a mouthpiece. Preferred configurations include circular, tubular, and rectangular. The means for storing the drug formulation may be configured to separately store one or more materials. In one embodiment, the means for storing the active agent is in the form of one or more drug discs, where the drug discs contain a plurality of blister packs, each storing one dose of the drug formulation. In another embodiment, the means for storing the active agent is a dosage cartridge containing a single dose of the drug formulation. In yet another embodiment, the drug formulation is stored on a ribbon containing a plurality of blister packs, each storing one dose of the drug formulation.

    摘要翻译： 本文描述了使干燥粉末制剂雾化以使其在口腔中形成细小涂层并且更具体地在口腔的舌下区域中的药物递送装置。 在优选实施例中，该装置包含五个主要部分：（i）压缩气体罐，（ii）分配器主体（在本文中也称为主壳体），（iii）用于存储一个或多个剂量的 药物制剂，（iv）用于释放剂量的药物制剂如气体罐或弹簧活塞的装置，（v）口器。 优选的构造包括圆形，管状和矩形。 用于储存药物制剂的方法可以被配置成分开存储一种或多种材料。 在一个实施方案中，用于储存活性剂的装置是一种或多种药物盘的形式，其中药物盘包含多个泡罩包装，每个存储一剂药物制剂。 在另一个实施方案中，用于储存活性剂的装置是含有单剂量药物制剂的剂量筒。 在另一个实施方案中，药物制剂储存在含有多个泡罩包装的条带上，每个存在一剂药物制剂。

    Rapid Acting and Long Acting Insulin Combination Formulations
    8.
    发明申请
    Rapid Acting and Long Acting Insulin Combination Formulations 有权
    快速作用和长效胰岛素组合配方

    公开(公告)号：US20080039365A1

    公开(公告)日：2008-02-14

    申请号：US11695562

    申请日：2007-04-02

    申请人： Solomon S. Steiner ,  Roderike Pohl

    发明人： Solomon S. Steiner ,  Roderike Pohl

    IPC分类号： A61K38/28 ,  A61K31/385 ,  A61K31/185 ,  A61K31/19 ,  A61K36/02

    CPC分类号： A61K38/28 ,  A61K31/185 ,  A61K31/19 ,  A61K31/385 ,  A61K2300/00

    摘要： A combined rapid acting-long acting insulin formulation has been developed wherein the pH of the rapid acting insulin is decreased so that the long acting glargine remains soluble when they are mixed together. In the preferred embodiment, this injectable basal bolus insulin is administered before breakfast, provides adequate bolus insulin levels to cover the meal, does not produce hypoglycemia after the meal and provides adequate basal insulin for 24 hours. Lunch and dinner can be covered by two bolus injections of a fast acting, or a rapid acting or a very rapid acting insulin. As a result, a patient using intensive insulin therapy should only inject three, rather than four, times a day. Experiments have been performed to demonstrate the importance of the addition of specific acids to hexameric insulin to enhance speed and amount of absorption and preserve bioactivity following dissociation into the monomeric form by addition of a chelator such as EDTA. As shown by the examples, the preferred acids are aspartic, glutamic and citric acid. These are added in addition to a chelator, preferably ethylenediaminetetraacetic acid (EDTA). The results show that the citric acid formulation was more effective at dropping the blood glucose rapidly than the identical rapid acting formulation prepared with HCl in swine. Charge masking by the polyacid appears to be responsible for rapid insulin absorption. EDTA was not effective when used with adipic acid, oxalic acid or HCl at hastening the absorption of insulin. These results confirm the results seen in clinical subjects and patients with diabetes treated with the rapid acting insulin in combination with citric acid and EDTA.

    摘要翻译： 已经开发了组合的快速作用长效胰岛素制剂，其中快速作用的胰岛素的pH降低，使得长效甘精胰醇混合在一起时仍然是可溶的。 在优选的实施方案中，这种可注射的基础推注胰岛素在早餐前施用，提供足够的推注胰岛素水平以覆盖膳食，在餐后不产生低血糖并提供足够的基础胰岛素24小时。 午餐和晚餐可以通过快速作用或快速作用或非常快速作用的胰岛素的两次快速注射来覆盖。 因此，使用强化胰岛素治疗的患者每天只能注射三次，而不是四次。 已经进行了实验以证明向六聚胰岛素中加入特定酸的重要性，以通过加入螯合剂如EDTA解离成单体形式来提高速度和吸收量并保持生物活性。 如实施例所示，优选的酸是天冬氨酸，谷氨酸和柠檬酸。 除了螯合剂，优选乙二胺四乙酸（EDTA）之外还加入它们。 结果表明，柠檬酸配方比在猪中​​用HCl制备的相同的快速作用制剂快速降低血糖。 多酸的电荷掩蔽似乎是快速胰岛素吸收的原因。 当与己二酸，草酸或HCl一起使用以加速胰岛素的吸收时，EDTA无效。 这些结果证实了临床受试者和用快速作用胰岛素与柠檬酸和EDTA组合治疗的糖尿病患者的结果。

    Rapid acting drug delivery compositions
    9.
    发明授权
    Rapid acting drug delivery compositions 有权
    快速作用药物输送组合物

    公开(公告)号：US07279457B2

    公开(公告)日：2007-10-09

    申请号：US11077604

    申请日：2005-03-11

    申请人： Roderike Pohl ,  Solomon S. Steiner

    发明人： Roderike Pohl ,  Solomon S. Steiner

    IPC分类号： A61K38/28 ,  C07K16/00

    CPC分类号： A61K9/006 ,  A61K9/0019 ,  A61K9/0056 ,  A61K38/28 ,  Y10S514/866 ,  Y10S514/951 ,  Y10S514/953 ,  Y10S514/959

    摘要： Drug formulations for systemic drug delivery with improved stability and rapid onset of action are described herein. The formulations may be administered via buccal administration, sublingual administration, pulmonary delivery, nasal administration, subcutaneous administration, rectal administration, vaginal administration, or ocular administration. In the preferred embodiments, the formulations are administered sublingually or via subcutaneous injection. The formulations contain an active agent and one or more excipients, selected to increase the rate of dissolution. In the preferred embodiment, the drug is insulin, and the excipients include a metal chelator such as EDTA and an acid such as citric acid. Following administration, these formulations are rapidly absorbed by the oral mucosa when administered sublingually and are rapidly absorbed into the blood stream when administered by subcutaneous injection. In one embodiment, the composition is in the form of a dry powder. In another embodiment, the composition is in the form of a film, wafer, lozenge, capsule, or tablet. In a third embodiment, a dry powdered insulin is mixed with a diluent containing a pharmaceutically acceptable carrier, such as water or saline, a metal chelator such as EDTA and an acid such as citric acid. Devices for storing and mixing these formulations are also described.

    摘要翻译： 本文描述了具有改善的稳定性和快速起效的全身药物递送的药物制剂。 制剂可以通过口腔给药，舌下给药，肺部输送，鼻内给药，皮下给药，直肠给药，阴道给药或眼部给药来施用。 在优选的实施方案中，制剂是舌下给药或通过皮下注射给药。 制剂含有活性剂和一种或多种赋形剂，其被选择以增加溶解速率。 在优选的实施方案中，药物是胰岛素，赋形剂包括金属螯合剂如EDTA和酸如柠檬酸。 给药后，这些制剂在舌下施用时被口腔粘膜快速吸收，并且当通过皮下注射给药时，其迅速地被吸收到血液流中。 在一个实施方案中，组合物为干粉的形式。 在另一个实施方案中，组合物为薄膜，晶片，锭剂，胶囊或片剂的形式。 在第三个实施方案中，将干粉状胰岛素与含有药学上可接受的载体如水或盐水，金属螯合剂如EDTA和酸如柠檬酸的稀释剂混合。 还描述了用于储存和混合这些制剂的装置。

    Insulin formulations for rapid uptake
    10.
    发明授权
    Insulin formulations for rapid uptake 有权
    胰岛素配方快速吸收

    公开(公告)号：US09060927B2

    公开(公告)日：2015-06-23

    申请号：US12397219

    申请日：2009-03-03

    申请人： Solomon S. Steiner ,  Roderike Pohl ,  Ming Li ,  Robert Hauser

    发明人： Solomon S. Steiner ,  Roderike Pohl ,  Ming Li ,  Robert Hauser

    IPC分类号： A61K38/28 ,  C07K14/62 ,  A61K9/00 ,  A61K38/00

    CPC分类号： A61K9/0019 ,  A61K38/00 ,  A61K38/28 ,  A61K47/12 ,  A61K47/183 ,  C07K14/62

    摘要： Injectable insulin formulations with improved stability and rapid onset of action are described herein. The formulations may be for subcutaneous, intradermal or intramuscular administration. In the preferred embodiment, the formulations are administered via subcutaneous injection. The formulations contain insulin in combination with a chelator and dissolution agent, and optionally additional excipients. In the preferred embodiment, the formulation contains human insulin, a zinc chelator such as EDTA and a dissolution agent such as citric acid or sodium citrate. These formulations are rapidly absorbed into the blood stream when administered by subcutaneous injection. In the preferred embodiment, the insulin is provided as a clear liquid, neutral pH, in a multi-use sterile vial. In an alternative embodiment, the insulin is provided as a powder in a sterile vial. This is mixed with a diluent containing a pharmaceutically acceptable carrier, such as water, a zinc chelator such as EDTA and a dissolution agent such as citric acid shortly before or at the time of administration. In another embodiment, the insulin is stored as a frozen mixture, ready for use upon thawing.

    摘要翻译： 本文描述了具有改善的稳定性和快速起效的可注射的胰岛素制剂。 制剂可用于皮下，皮内或肌内给药。 在优选的实施方案中，通过皮下注射施用制剂。 制剂含有与螯合剂和溶解剂以及任选的其它赋形剂组合的胰岛素。 在优选的实施方案中，制剂含有人胰岛素，锌螯合剂如EDTA和溶解剂如柠檬酸或柠檬酸钠。 当通过皮下注射给药时，这些制剂被快速地吸收到血流中。 在优选的实施方案中，胰岛素以多用途无菌小瓶中的透明液体中性pH提供。 在替代实施方案中，胰岛素以无菌小瓶中的粉末形式提供。 将其与包含药学上可接受的载体如水，锌螯合剂如EDTA的稀释剂和不久之前或给药时的溶解剂如柠檬酸混合。 在另一个实施方案中，将胰岛素作为冷冻混合物储存，准备在解冻时使用。